Custom oral appliances, placed in the mouth similar to mouthguards, are increasingly becoming a popular alternative treatment option for individuals with obstructive sleep apnea (OSA). Most work by supporting the jaw in a forward position to help maintain an open upper airway during sleep, though some use other mechanisms of action. Unlike CPAP machines, oral appliances for OSA do not require a power source.
A clinical practice guideline published jointly in 2015 by the American Academy of Sleep Medicine and American Academy of Dental Sleep Medicine recommends that sleep physicians consider prescription of oral appliance therapy for adult patients with OSA who are intolerant of CPAP therapy or prefer an alternate therapy.
CPAP is superior to oral appliance therapy in improving AHI and lowering both the arousal index and the oxygen desaturation index. However, the efficacy gap between CPAP and oral appliance therapy may be closed when adherence is taken into consideration.
Researchers continue to evaluate potential predictors of success for oral appliance therapy while developing tools and processes that may improve appliance selection and titration.
This guide compares oral appliances side-by-side on parameters including warranty, materials, PDAC verification, how it works, fitting, adjustment, and supporting study.
The custom oral appliances for OSA compared are:
AIOMEGA Biotechnologies AIO Breathe
Airway Management flexTAP
Apex Dental Sleep Lab EMA Serena Nylon
Dream Systems O2 OASYS
Glidewell Silent Nite 3D Sleep Appliance
Glidewell Silent Nite Sleep Appliance
Great Lakes Dental Technologies Nylon Sleep Herbst
LeBlanc Dental Products The Slide
Open Airway Dental Solutions O2Vent Optima
Panthera Classic
Panthera X3
ProSomnus EVO Guided
ProSomnus EVO SELECT
ProSomnus EVO
ProSomnus EVO [PH]
![ProSomnus EVO [PH]](https://sleepreviewmag.com/wp-content/uploads/2024/09/ProSomnus-EVO-PH-2-2500x1273.jpg)
SICAT GmbH & Co KG OPTISLEEP
Slow Wave DS8
SomnoMed SomnoDent Herbst Advance Elite
Vivos Therapeutics Inc DNA
| Company: | AIOMEGA Biotechnologies | Airway Management Inc | Apex Dental Sleep Lab | Dream Systems Dental Sleep Lab | Glidewell | Glidewell | Great Lakes Dental Technologies | LeBlanc Dental Products | Open Airway Dental Solutions Ltd | Panthera Dental | Panthera Dental | ProSomnus Sleep Technologies | ProSomnus Sleep Technologies | ProSomnus Sleep Technologies | ProSomnus Sleep Technologies | SICAT GmbH & Co KG | Slow Wave Inc | SomnoMed | Vivos Therapeutics Inc |
| Appliance: | AIO Breathe | flexTAP | EMA Serena Nylon | O2 OASYS Oral / Nasal Airway System (Optional Nasal Dilators & Tongue Repositioning Buttons) | Silent Nite 3D Sleep Appliance | Silent Nite Sleep Appliance | Nylon Sleep Herbst | The Slide | O2Vent Optima | Panthera Classic | Panthera X3 | ProSomnus EVO Guided | ProSomnus EVO SELECT | ProSomnus EVO | ProSomnus EVO [PH] | SICAT OPTISLEEP | Slow Wave DS8 | SomnoDent Herbst Advance Elite | DNA |
| Website: | aiomd.com | tapintosleep.com | apexsleep.com | dreamsystemsdentallab.com | glidewell.com/3d-silent-nite | glidewell.com/silent-nite | gldt.com | slide2sleep.com | openairway.com | pantherasleep.com | pantherasleep.com | prosomnus.com | prosomnus.com | prosomnus.com | prosomnus.com | sicat.com | slowwave.net | somnomed.com/en/dentists/products | vivoscare.com |
| Warranty (days): | 1,095 | 1,095 | 730 | 730 | 1,095 | 1,095 | 730 | 1,095 | 1,095 | 1,095 | 1,095 | 1,095 | 1,095 | 1,095 | 1,095 (+730 for Medicare beneficiaries) | 730 | 1,095 | 730 | 60 |
| Indications: | Mild-Moderate OSA, Snoring | Mild-Moderate OSA, Snoring | Mild-Moderate OSA, Snoring | Mild-Moderate OSA, Snoring | Mild-Moderate OSA, Snoring | Mild-Moderate OSA, Snoring | Mild-Moderate OSA, Snoring | Mild-Moderate OSA, Snoring | Mild-Moderate OSA, Snoring | Mild-Moderate OSA, Snoring | Mild-Moderate OSA, Snoring | Mild-Moderate OSA, Snoring | Mild-Moderate OSA, Snoring | Mild-Moderate OSA, Snoring | Mild-Moderate OSA, Snoring | Mild-Moderate OSA, Snoring | Mild-Moderate OSA, Snoring, Bruxism | Mild-Moderate OSA, Snoring | Mild-Moderate OSA, Severe OSA, Snoring |
| Materials: | Biocompatible polymer, Metal-Free (ISO 10993 certified for perpetual use in oral cavity) | Thermal Acrylic, Laminate, no metal parts | Nylon | Biocompatible Polymer, Cobalt-Chromium Alloys, Stainless Steel, Hard Acrylic, Laminate, Thermal Acrylic | Biocompatible Polymer, Metal-Free | Biocompatible Polymer, Ethylene-vinyl Acetate, Thermal Acrylic, Metal-Free | Nylon | Acrylic or Nylon | Nylon, 3D printed | Biocompatible Polymer, Nylon | Biocompatible Polymer, Nylon | Biocompatible Polymer, Medical grade class VI | Biocompatible Polymer, Medical grade class VI | Biocompatible Polymer, Medical grade class VI | Biocompatible Polymer, Stainless Steel, Medical grade class VI | Biocompatible Polymer, Hard Acrylic, Nylon | Hard Acrylic, BioMed Clear | Biocompatible Polymer, Cobalt-Chromium Alloys, Stainless Steel, Hard Acrylic | Stainless Steel, Hard Acrylic |
| PDAC Verified: | Pending | Yes | No | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | No | Yes | Yes | No | Yes | Yes | No |
| How Does the Oral Appliance Work?: | Pan-airway enlargement. Individually customizable flange/plateau/thickness technology (Connected-Arc-of-Motion) guides mandible up or down, front or back to enlarge the entire airway. Breath-to-breath airflow modulation adjusts airflow to the user’s real-time oxygen demand (Revive On-Demand Airflow). Design minimizes anterior advancement requirements, reducing TMJ stress. | FlexTAP advances the lower jaw with a single point midline advancement. Self-titratable adjustments in 1/3 mm increments aid in easier, faster, and better treatment outcomes. | Uses Frantz Design Patent Elastic Mandibular Advancement straps that have been used to treat mild to moderate sleep apnea for over 25 years to position the jaw forward while managing comfort and durability with biocompatible nylon. | The Oasys Simplicity provides mandibular advancement. The standard Oasys with Nasal Dilators improves nasal breathing and adding Tongue Lifters improves forward tongue positioning. | 3D-printed mandibular advancement device. Connectors on right and left buccal side will pull the mandible in protrusion to open up the airway. Adjustable, up to 10 mm of advancement. | Thermoformed mandibular advancement device. Connectors on right and left buccal side will pull the mandible in protrusion to open up the airway. 6 adjustable settings. | Mandibular position is set to open the airway and hold this position while sleeping. | It slides the lower jaw forward and holds it there. | O2Vent Optima has two mechanisms of action that add stability to the airway. 1. A mechanism of advancing the jaw forward encouraging a more open airway. 2. Incorporates an airway channel that further stabilizes the airway. | Uses traction-based titration to minimize joint strain while promoting lip seal. 3D printed from durable PA2200 nylon, designed for maximized tongue space and comfort. | A single set of upper and lower splints are adjusted using an interchangeable clip system. 3D printed from durable PA2200 nylon, designed for maximized tongue space and comfort. Maximizes tongue space and avoids soft tissue contact. | ProSomnus EVO Guided uses a 95-degree lower guided post and upper posterior block to stabilize and hold the mandible forward. EVO Guided is engineered to dilate the velopharynx and the oropharynx. | ProSomnus EVO SELECT uses vertically mated buccal posts to advance and hold the mandible forward to open the airway. | ProSomnus EVO uses vertically mated buccal posts to advance and hold the mandible forward to open the airway. | The ProSomnus [PH] uses a continuous advancement protocol. Upper arch connects via Herbst Arm to lower arch with an adjustment nut. | The airway is kept open by protrusion of the mandible with a 2-part appliance. It allows for lateral movement and mouth opening. | Incorporates a vertical opening and makes more room for the tongue. Also stimulates the user’s brain to naturally migrate the tongue forward during sleep. | The device functions as a mandibular repositioner, which acts to increase the patient’s pharyngeal space during sleep. | Mandibular and maxillary slow expansion. |
| Intraoral-Scan Impression Compatible: | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
| Max Protrusion/ Max Retrusion/Adjustment Increment (mm): | Anterior: 15, Vertical: 36/ 5/ 0.06 | 17/ 2/ 0.333 | 9/ 0/ 1 | 15/ 5/ 1 | 10/ 0.5/ 0.5 | 6/ 1/ 1 | 4/ 1 /<0.25 | 8/ 4/ 1 | 6/ 2/ 1 | N/A/ N/A/ 0.5 | 5/ -1/ 0.5 | unlimited/ customizable/ 1 | unlimited/ customizable/ 1 | unlimited/ customizable/ 1 | 12/ -1/ 0.1 | 9/ 9/ 1 | 2/ 2/ N/A (no adjustments needed) | 8/ -1/ 0.1 | 5/ 5/ 0.2 |
| Upper-Lower Connection: | Connected | Connected | Connected | Not connected | Connected | Connected | Connected | Connected | Connected | Connected | Not connected | Not connected | Not connected | Not connected | Connected | Connected | Not connected | Connected | Not connected |
| Custom Accessories Available: | AIOMEGA APP (available on Apple and Google stores) for personalized and physician/dentist for tracking sleep/fitness/nutrition/hydration/weight management. Portable carrying case. | Mouth Shield nasal breathing trainer, AM Aligner morning repositioner. | [info not provided] | Retention clasps, hooks & elastics, in combination with Invisalign. | Shipped with extra connectors, complimentary AM Aligner. | Shipped with extra connectors, complimentary AM Aligner. | Advancement shims, ‘C’ cut shims, elastics, telescopic hardware. | AM aligner included. | Connector bands, biteforks. | Pairs of interchangeable elongation-proof rods allow for a titration range from 16 mm to 34 mm in 0.5 mm increments. | Titration clips (allow adjustment from -1 mm to +5 mm in 0.5 mm increments). | Monogram customization options. | Monogram customization options. | Monogram customization options. | Monogram customization options. | None. | None. | Distal wrap, breathing hole, edentulous, cheek protector option, discluding element. | None. |
| Supporting Study: | Ghuge R, Ghuge A. 0796 AIO BREATHE for OSA: Matching Airflow to Oxygen Demand with CONNECTED-ARC-OF-MOTION, AI-PREDICTIVE Oral Device Geometry and ON-DEMAND-AIRFLOW Delivery. Sleep. 2025 May;48 (suppl_1):A344–5. | tapintosleep.com/peer-reviewed-studies | [info not provided] | Shrivastava D, Bixby JK, Livornese DS, et al. Efficacy of oral appliance therapy in the treatment of severe OSA in CPAP-resistant cases. Sleep Vigilance. 2018. | Not provided. | Borrie F, Keightley A, Blacker S, Serrant P. Mandibular advancement appliances for treating sleep apnoea/hypopnoea syndrome. Evid Based Dent. 2013 Mar;14(1):27-8. | Not provided. | In progress. | openairway.com/pages/clinical-resources | Not provided. | Not provided. | Not provided. | Not provided. | Mosca E, Remmers J. Precision vs traditional oral appliance therapy: A comparison of therapeutic efficacy. JDSM 10.2. Abstract #006. | Not provided. | Not provided. | Not provided. | Phillips CL, Grunstein RR, Darendeliler MA, et al. Health outcomes of continuous positive airway pressure versus oral appliance treatment for obstructive sleep apnea: a randomized controlled trial. Am J Respir Crit Care Med. 2013 Apr 15;187(8):879-87. | Katz D, DeMaria S, Heckman S, et al. Use of the Complete Airway Repositioning and Expansion (CARE) approach in 220 patients with obstructive sleep apnea (OSA): A retrospective cohort study. Sleep Med. 2022 Nov;99:18-22. |
| Features: | Patented AI tool (AIO-P-AI) needs only two inputs (AHI/LSAT) pre-therapy to achieve desired therapy improvement (AHI/LSAT) in OSA. | 60-day satisfaction guarantee. Precision-fit ThermAcryl trays allow for minor chairside adjustments using warm water. Every appliance is shipped with a Mouth Shield nasal breathing trainer and AM Aligner. | Made of durable, thin biocompatible nylon. | Unique applications with upper denture, minimal dentition upper or lower, nasal obstruction or resistance, in combination with Invisalign. | Silent Nite has a 90-day “stops snoring or your money back” guarantee. | Silent Nite has a 90-day “stops snoring or your money back” guarantee. | Allows lateral and vertical movement without disengaging the appliance. Made less than 1 mm thick, retains durability and retention while maintaining appropriate flexibility. | The Slide places all adjustable components over the biting surfaces of the teeth, away from all the oral tissue. | The O2Vent Optima products are OADS’ latest offering in the O2Vent oral appliance range. The lower jaw can be moved forward to a comfortable range while also allowing the integrated airway channel to bypass nasal congestion and other areas of airway collapse, such as from the tongue, soft palate, and lateral walls. | Medicare E0486 reimbursable low profile and lightweight appliance. 8-day turnaround time. 3-year no-questions asked 360 warranty. Engineered using proprietary design software and manufactured using Smart Technologies combining robotics, AI, and automation. Finished using an exclusive polishing process. | Low profile and lightweight dorsal fin appliance. 8-day turnaround time. 3-year no-questions asked 360 warranty. Engineered using proprietary design software and manufactured using Smart Technologies combining robotics, AI, and automation. Finished using an exclusive polishing process. | EVO Guided is engineered to prevent airway collapse by repositioning the hyo-glossal complex by guiding and repositioning the mandible, guiding and encouraging an anterior tongue posture, guiding mouth closure. EVO Guided is 100% made from the patient’s oral records, no prefabricated components and no modifications from the provider’s prescription. | Engineered for performance, biocompatibility, and the greatest comfort. A signature variation of the ProSomnus EVO device, EVO SELECT is optimized for patients who may benefit from a more compact, effective, and easy to use precision OAT medical device using innovative materials. | Incorporates advanced materials, manufacturing robotics, and AI to advance the treatment of OSA using a precision platform. In a controlled IRB study (2021), 100% of patients preferred EVO over previous devices and CPAP; 100% of providers would recommend EVO; and 100% of providers stated EVO was easy to deliver. Features MG6 technology. | ProSomnus EVO [PH], FDA cleared and Medicare E0486 verified. EVO [PH] is a dual arm advancement device with innovative materials, manufacturing robotics, and AI designed to provide a better experience for all patients. | A transparent and aesthetic therapeutic appliance, comfortable to wear thanks to its slim design. Milled from biocompatible, odorless, and non-discoloring PMMA. 100% preliminary check of STL data to ensure the feasibility and accuracy of fit, enabling individual adjustments after consultation with the practitioner. | Infinitely adjustable ramp system allows the brain to locate perfect jaw resting spot for each patient. | Individually milled from one piece of pre-cured PMMA for greater flexural strength. All the patented strength improvements in the Herbst Advance are also found in the Herbst Advance Elite. SomnoMed will replace it for free if it breaks, no questions asked, for 3 years. The Herbst Advance Elite is only supplied with a Bflex soft inner liner for increased comfort and retention. | Not provided. |
Information for this guide based on data submitted by custom oral appliance marketers. Sleep Review strives for accuracy in all data but cannot be held responsible for claims made by marketers. All custom oral appliance marketers get one listing at no charge. Advertisers are offered multiple listings. All custom oral appliance options may not be included. Email editor[at]sleepreviewmag.com to be considered for the next update.
Are there differences in terms of comfort or sensitivity by the ones that have metal in it? From all of these the Silent Nite looks most appealing and comfortable …